A common practice in gynecology is for a woman to have an annual examination including speculum and bimanual examination and a Papanicolau smear (which primarily screens for cervical cancer). On the other hand, there is no current screening test for endometrial cancer, the most prevalent form of gynecological cancer. Therefore imaging and biopsy is usually delayed until after symptoms develop. Patients with endometrial carcinoma or hyperplasia typically exhibit increased or irregular menses or postmenopausal vaginal bleeding (PMB). The standard of care as recommended by the American College of Obstetricians and Gynecologists is for patients with these symptoms to undergo office-based endometrial biopsy (EMB) and endocervical curettage (ECC). The EMB is a blind biopsy done typically with an endometrial Pipelle™. The Pipelle™ is a disposable plastic tube measuring approximately 3.1 mm in diameter with an internal plunger which is drawn back to create a small amount of suction once the device has been introduced into the endometrial cavity via the cervix. By moving the device in and out, a sample of endometrial tissue is removed for histologic examination.
None of the above techniques use imaging of the endometrium. There are currently two imaging modalities that are available. The first is transvaginal ultrasound, which may be useful in screening patients with PMB for endometrial cancer. The other technique for imaging the endometrium is hysteroscopy. Not surprisingly, using the hysteroscope for image-guided biopsy has been shown to be superior to the above blind procedures. However, the majority of gynecologists do not perform hysteroscopy. In addition to the issues of pain, invasiveness, and morbidity, there is a steep learning curve. In addition, the use of a distending media, for example, saline or a gas (e.g., CO2) to create open space in the uterus, may lead to problems. In addition, because the hysteroscope can only image the tissue in front of it, experience and manual dexterity are required in order to examine the whole endometrium.